NCT01192945已完成不适用
Piaza - Non-interventional Study on the Efficacy and Safety of Azacitidin (Vidaza®) in Patients With Myelodysplastic Syndromes (MDS, INT-2 or High Risk), AML (WHO 20-30% Blasts), or CMMoL (10-29% Bone Marrow Blasts Without Myeloproliferative Disorder)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-free-survival
研究概览
简要总结
The purpose of this non-interventional study is to collect data on the efficiency and safety of Azacitidin in the routine application.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are not eligible for haematopoietic stem cell transplantation, who are at least 18 years old (no age limit to top) and who have one of the following diseases:
- •myelodysplastic syndrome (MDS) with intermediate risk 2 or high risk according to the International Prognostic Scoring System (IPSS)
- •chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder
- •acute myeloid leukemia (AML) with 20-30% blasts and multilineage dysplasia according to classification of the World Health Organisation (WHO).
排除标准
- •Contraindication according to the summary of product characteristics of Vidaza®
- •Signed patient informed consent form is not available
- •Patients with advanced malignant hepatic tumors
- •Pregnant or nursing women, men and women (of childbearing age) who are unwilling to apply a reliable method of contraception during and up to three months after treatment with Azacitidine
- •Necessary or planned treatment with other systemic cytostatics
- •Known medical history of severe decompensatoric cardiac insufficiency
- •Medical history of clinically unstable cardiac or pulmonary disease
- •Known or suspected hypersensitivity to azacitidine or mannitol
结局指标
主要结局
Progression-free-survival
时间窗: 2 years after LPI
次要结局
- relative dosage of azacitidine(2 years after LPI)
- overall survival(2 years after LPI)
- liver and kidney functionality(2 years after LPI)
- 2 year survival rate(2 years after LPI)
- overall response rate(2 years after LPI)
- haematological improvement(2 years after LPI)
- time to treatment discontinuation(2 years after LPI)
- blood transfusion requirements(2 years after LPI)
- supportive medication(2 years after LPI)
研究者
研究点 (1)
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